Common Warts Clinical Trial
Official title:
Nanopulse Efficacy Study for the Treatment of Common Warts
The purpose of this study is to determine if the Nanopulse System can be used to clear common
wart lesions on the skin. The Nanopulse System uses a series of low energy, high voltage
pulses, each one several billionths of a second in duration, to effectively kill the target
tissue contained within the applicator tip electrodes with minimal damage to surrounding
tissue. Efficacy and patient outcomes are expected to equal or surpass current treatment
modalities in terms of increased ease of use, faster patient healing and minimal scarring
with fewer complications resulting from treatment.
The device emits significantly less energy than existing electro-surgery or electro-cautery
equipment and is believed to be similar to laser therapy treatment of warts. Trained
clinicians can usually diagnose warts based by their appearance and location . Non-genital
warts are subcategorized into common, periungual, flat, filiform, and plantar types. Common
warts are benign, often skin-colored, or brown-grey, rough, bumpy growths on the hands and
feet (caused by Human Papilloma Virus type 2) . Common warts in individuals without any
immune deficiencies are low risk and are the focus of this study.Based upon the preclinical
profile of the Nanopulse device, particularly its safety profile and its effect on
transformed cells, it is hypothesized that application of pulses from the Nanopulse System ,
will result in complete clinical clearance of Common Wart lesions with minimal scarring.
Study Objective: The objective of this study is to indicate whether the Nanopulse System is
efficacious for use in clearing common warts.
The primary objective of this study is to gather lesion clearance data on common warts after
application of pulses from the Nanopulse System and determine the optimal number of
treatments necessary. Clearance will be measured by clinical observation.
Other objectives of the study include gathering efficacy data on the use of the Nanopulse
System for treating common warts in terms of:
1.) Safety in a clinical setting in terms of minimal adverse events over the course of the
trial; 2.) Cosmetic results during the healing process and cosmetic outcome; 3.)Effects of 1,
2, 3 or 4 treatments in terms of clearance and cosmetic outcome for each treated wart;
4.)Subject impressions immediately following application of pulses; 5.)Subject satisfaction
with the treatment and cosmetic outcome during and following the healing process; 6) Device
performance and clinical feedback under actual clinical conditions and to gather information
on design features that may be modified to optimize the device.
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